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Ultrasound Guided Knee Injections in Musculoskeletal Medicine (PRISMM)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Joint line ultrasound
Joint line landmark
Suprapatellar ultrasound guided
Suprapatellar Landmark
Sponsored by
Andrews Research & Education Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, osteoarthritis, ultrasound, sonography, injection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, age 18 to 90
  • Clinician determined need for intra-articular knee injection
  • Radiograph confirmed grade 1-4 Kellgren Lawrence osteoarthritis scale

Exclusion Criteria:

  • Allergy to contrast dye, shellfish
  • Allergy to egg product or hyaluronate
  • Allergy to lidocaine
  • Localized skin infection at planned site of injection
  • Inability to complete follow-up phone call three months following the injection
  • Viscosupplementation injection within 6 months of the current evaluation

Sites / Locations

  • Andrews Research & Education Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

Joint Line Ultrasound

Joint Line Landmark

Suprapatellar Ultrasound Guided

Suprapatellar Landmark

Arm Description

Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.

Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.

Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.

Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance.

Outcomes

Primary Outcome Measures

Number of Participants With Successful Knee Injection
To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.

Secondary Outcome Measures

Procedural Satisfaction Score at 3 Months Post Injection
Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Compare the Western Ontario and McMaster Universities Osteoarthritis Index between groups at the 3-month follow-up appointment. The scale is 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Full Information

First Posted
September 18, 2017
Last Updated
August 4, 2022
Sponsor
Andrews Research & Education Foundation
Collaborators
American Medical Society for Sports Medicine (AMSSM)
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1. Study Identification

Unique Protocol Identification Number
NCT03293238
Brief Title
Ultrasound Guided Knee Injections in Musculoskeletal Medicine
Acronym
PRISMM
Official Title
Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2011 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andrews Research & Education Foundation
Collaborators
American Medical Society for Sports Medicine (AMSSM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the accuracy and patient reported outcomes between four different techniques used to perform a knee injection.
Detailed Description
This study will compare the accuracy and patient-oriented outcomes between various techniques for intra-articular knee injections. Historically, a joint line (intercondylar) technique of injection at the medial or lateral joint line, reliant solely upon clinical palpation, has been the most popular approach among primary care and orthopedic providers. Newer approaches, making use of ultrasound visualization to accomplish access to the intercondylar recess and the anterolateral suprapatellar pouch, have gained in popularity. Because of uncertain accuracy with the traditional approach, this study is designed to determine if sonographic visualization combined with either of these two newer techniques improves accuracy and affects patient-oriented outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee, osteoarthritis, ultrasound, sonography, injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized into one of four intervention arms for the purpose of obtaining patient reported outcomes as it relates to the accuracy of injections into the knee joint with or without ultrasound guidance.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients will be blindfolded for the duration of their procedure. Investigator will always place ultrasound probe on patient's knee regardless of group assignment to eliminate bias. To further enhance blinding, the ultrasound screen will placed on freeze for the patients randomized into the groups without ultrasound guidance. Radiologist will be blinded to patient's group assignment.
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Joint Line Ultrasound
Arm Type
Active Comparator
Arm Description
Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.
Arm Title
Joint Line Landmark
Arm Type
Sham Comparator
Arm Description
Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.
Arm Title
Suprapatellar Ultrasound Guided
Arm Type
Active Comparator
Arm Description
Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.
Arm Title
Suprapatellar Landmark
Arm Type
Sham Comparator
Arm Description
Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Joint line ultrasound
Other Intervention Name(s)
JLUS
Intervention Description
Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will be aided by real time visualization utilizing ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Joint line landmark
Other Intervention Name(s)
JLL
Intervention Description
Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.
Intervention Type
Procedure
Intervention Name(s)
Suprapatellar ultrasound guided
Other Intervention Name(s)
SPUS
Intervention Description
Patients will be lying supine on exam table. Ultrasound will be used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa will be made within the suprapatellar pouch.
Intervention Type
Procedure
Intervention Name(s)
Suprapatellar Landmark
Other Intervention Name(s)
SPL
Intervention Description
Patients will be lying supine on exam table. Injecting physician will insert needle lateral to the vastus lateralis toward the suprapatellar pouch, and will inject of Euflexxa once it is believed that the needle tip is in the pouch.
Primary Outcome Measure Information:
Title
Number of Participants With Successful Knee Injection
Description
To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.
Time Frame
Procedure visit 3 (3-4 weeks after 1st injection)
Secondary Outcome Measure Information:
Title
Procedural Satisfaction Score at 3 Months Post Injection
Description
Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.
Time Frame
3 month follow-up appointment following 3rd injection
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Description
Compare the Western Ontario and McMaster Universities Osteoarthritis Index between groups at the 3-month follow-up appointment. The scale is 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Pre-Injection and 3 month follow-up appointment following 3rd injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age 18 to 90 Clinician determined need for intra-articular knee injection Radiograph confirmed grade 1-4 Kellgren Lawrence osteoarthritis scale Exclusion Criteria: Allergy to contrast dye, shellfish Allergy to egg product or hyaluronate Allergy to lidocaine Localized skin infection at planned site of injection Inability to complete follow-up phone call three months following the injection Viscosupplementation injection within 6 months of the current evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Hackel, MD
Organizational Affiliation
Andrews Institute for Orthopaedic & Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andrews Research & Education Foundation
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11156538
Citation
Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.
Results Reference
background
PubMed Identifier
12208907
Citation
Jackson DW, Evans NA, Thomas BM. Accuracy of needle placement into the intra-articular space of the knee. J Bone Joint Surg Am. 2002 Sep;84(9):1522-7. doi: 10.2106/00004623-200209000-00003.
Results Reference
background
PubMed Identifier
19062223
Citation
Wiler JL, Costantino TG, Filippone L, Satz W. Comparison of ultrasound-guided and standard landmark techniques for knee arthrocentesis. J Emerg Med. 2010 Jul;39(1):76-82. doi: 10.1016/j.jemermed.2008.05.012. Epub 2008 Dec 5.
Results Reference
background
PubMed Identifier
17149645
Citation
Esenyel C, Demirhan M, Esenyel M, Sonmez M, Kahraman S, Senel B, Ozdes T. Comparison of four different intra-articular injection sites in the knee: a cadaver study. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):573-7. doi: 10.1007/s00167-006-0231-6. Epub 2006 Dec 6.
Results Reference
background
PubMed Identifier
14760802
Citation
Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar B, Uson J, Palop MJ, Crespo M. A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. J Rheumatol. 2004 Feb;31(2):308-14.
Results Reference
background
PubMed Identifier
22500117
Citation
Berkoff DJ, Miller LE, Block JE. Clinical utility of ultrasound guidance for intra-articular knee injections: a review. Clin Interv Aging. 2012;7:89-95. doi: 10.2147/CIA.S29265. Epub 2012 Mar 20.
Results Reference
background
PubMed Identifier
20222114
Citation
Cunnington J, Marshall N, Hide G, Bracewell C, Isaacs J, Platt P, Kane D. A randomized, double-blind, controlled study of ultrasound-guided corticosteroid injection into the joint of patients with inflammatory arthritis. Arthritis Rheum. 2010 Jul;62(7):1862-9. doi: 10.1002/art.27448.
Results Reference
background
PubMed Identifier
19854960
Citation
Im SH, Lee SC, Park YB, Cho SR, Kim JC. Feasibility of sonography for intra-articular injections in the knee through a medial patellar portal. J Ultrasound Med. 2009 Nov;28(11):1465-70. doi: 10.7863/jum.2009.28.11.1465.
Results Reference
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PubMed Identifier
20531157
Citation
Hong BY, Lim SH, Cho YR, Kim HW, Ko YJ, Han SH, Lee JI. Detection of knee effusion by ultrasonography. Am J Phys Med Rehabil. 2010 Sep;89(9):715-21. doi: 10.1097/PHM.0b013e3181e29c55.
Results Reference
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Ultrasound Guided Knee Injections in Musculoskeletal Medicine

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